U.S. patent number 11,260,563 [Application Number 14/838,205] was granted by the patent office on 2022-03-01 for apparatus and method for producing a biocompatible three-dimensional object.
This patent grant is currently assigned to S.M. Scienzia Machinale SRL. The grantee listed for this patent is S.M. Scienzia Machinale S.R.L.. Invention is credited to Marco Bacchereti, Luca Bosio, Giorgio Soldani.
United States Patent |
11,260,563 |
Bacchereti , et al. |
March 1, 2022 |
Apparatus and method for producing a biocompatible
three-dimensional object
Abstract
An apparatus for making a biocompatible three-dimensional object
including at least one delivery unit arranged to deliver at least
one biocompatible fluid substance towards a support body having a
matrix surface to obtain a coating layer of a predetermined
thickness configured for coating the matrix surface. Furthermore, a
handling unit is provided arranged to provide a relative movement
according to at least 3 degrees of freedom between the support body
and each delivery unit. The support body is arranged to be coated
by the delivered biocompatible fluid substance, in order to obtain
a three-dimensional object having an object surface copying the
matrix surface of the support body.
Inventors: |
Bacchereti; Marco (Cascina,
IT), Bosio; Luca (Pisa, IT), Soldani;
Giorgio (Massa, IT) |
Applicant: |
Name |
City |
State |
Country |
Type |
S.M. Scienzia Machinale S.R.L. |
Cascina |
N/A |
IT |
|
|
Assignee: |
S.M. Scienzia Machinale SRL
(Cascina, IT)
|
Family
ID: |
1000006143204 |
Appl.
No.: |
14/838,205 |
Filed: |
August 27, 2015 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20150367542 A1 |
Dec 24, 2015 |
|
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
PCT/IB2014/059291 |
Feb 27, 2014 |
|
|
|
|
Foreign Application Priority Data
|
|
|
|
|
Mar 7, 2013 [IT] |
|
|
PI2013A0015 |
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B29C
41/08 (20130101); A61F 2/062 (20130101); A61F
2/2481 (20130101); B29C 41/365 (20130101); B29L
2031/7532 (20130101); B29C 41/34 (20130101); B29K
2995/0056 (20130101) |
Current International
Class: |
B29C
41/36 (20060101); B29C 41/08 (20060101); A61F
2/06 (20130101); A61F 2/24 (20060101); B29C
41/34 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
H9-314305 |
|
Dec 1997 |
|
JP |
|
2006509658 |
|
Mar 2006 |
|
JP |
|
2012-236125 |
|
Jun 2012 |
|
JP |
|
2002045933 |
|
Jun 2002 |
|
WO |
|
2010059834 |
|
May 2010 |
|
WO |
|
2010136983 |
|
Dec 2010 |
|
WO |
|
2013019416 |
|
Feb 2013 |
|
WO |
|
2014136021 |
|
Sep 2014 |
|
WO |
|
Other References
Pre-Appeal Report for Appeal No. 2019-015002 (and translation) in
co-pending Japanese National Phase No. 2015-560819 (of
PCT/IB2014/059291) dated Jan. 6, 2020. cited by applicant .
International Search Report and Written Opinion of the
International Searching Authority in PCT Application No.
PCT/IB2016/001377, dated Mar. 22, 2018. cited by applicant.
|
Primary Examiner: Daniels; Matthew J
Assistant Examiner: Ameen; Mohammad M
Attorney, Agent or Firm: Steptoe & Johnson LLP
Greenfeld; Robert
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of International Application No.
PCT/IB2014/059291, filed Feb. 27, 2014, which claims priority to
Italian Patent Application No. PI2013A000015, filed Mar. 7, 2013,
each of which is incorporated by reference in its entirety.
Claims
What is claimed:
1. An apparatus for making a biocompatible three-dimensional
object, the apparatus comprising: a support body having a matrix
surface with at least two radii of curvature; a handling unit
supporting the support body; a delivery system arranged to deliver
a biocompatible fluid substance having a plurality of particles
towards the support body to obtain a coating layer of a
predetermined thickness coating the matrix surface; a control unit
arranged to monitor the thickness of the coating layer; a single
suction and blowing device arranged to generate a suction or
blowing current, the suction and blowing current configured to
remove from the support body any surplus particles of the
biocompatible fluid substance supplied by the delivery system; and
a counter-mold that is adapted, once the delivery of the
biocompatible fluid substance is completed, to press the coating
layer deposited on the support body, wherein the handling unit is
arranged to generate a relative movement with at least three
degrees of freedom between the support body and the delivery
system, in such a way that the support body can be coated with the
delivered biocompatible fluid substance to obtain a
three-dimensional object having an object surface corresponding to
the matrix surface of the support body.
2. The apparatus of claim 1, wherein the handling unit includes an
anthropomorphic robot having a chain of pivot joints, the chain of
pivot joints having an end connected to a fixed base and the other
end connected to a support base to which the support body or the
delivery system can be removably mounted, the chain of pivot joints
arranged to move the support body or the delivery system, according
to at least six degrees of freedom.
3. The apparatus of claim 1, wherein the handling unit includes a
plurality of linear actuators, each actuator of the plurality
having an end engaged with a fixed base and another end engaged
with a support base to which the support body or the delivery
system is removably mounted.
4. The apparatus of claim 1, wherein the suction and blowing device
is fixed.
5. The apparatus of claim 1, wherein the suction and blowing device
is movable and associated with auxiliary moving means arranged to
move the suction and blowing device, the auxiliary moving means
being configured to allow the suction and blowing device to follow
spatially the position of the support body during its handling by
the handling unit.
6. The apparatus of claim 1, wherein the suction and blowing device
includes a suction hood integral to the support base and configured
to surround laterally the support body, in order to maximize the
suction of the surplus particles of the biocompatible fluid
substance, and a suction tube arranged to connect pneumatically the
suction hood with a suction system.
7. The apparatus of claim 1, wherein the delivery system includes a
first delivery unit arranged to deliver a first jet of the
biocompatible fluid substance towards the support body, the
biocompatible fluid substance being a biomaterial of synthetic
origin, and a second delivery unit arranged to deliver a second jet
of a second biocompatible fluid substance towards the support body,
the second biocompatible fluid substance being a non-solvent, the
second delivery unit arranged to direct the second jet towards the
support body in such a way that the second jet overlaps the first
jet, inducing a quick deposit of the synthetic biomaterial supplied
onto the support body from the first delivery unit obtaining a
filamentous three-dimensional structure.
8. The apparatus of claim 7, wherein the second biocompatible fluid
substance is water.
9. The apparatus of claim 7, wherein the delivery system includes a
third delivery unit arranged to deliver a third biocompatible fluid
substance.
10. The apparatus of claim 9, wherein the third biocompatible fluid
substance is a biopolymeric material of synthetic origin.
11. The apparatus of claim 1, wherein the thickness of the coating
layer is capable of being adjusted.
Description
FIELD
The present disclosure relates to an apparatus for making a
biocompatible three-dimensional object with complex shape, i.e.
made of two or more surfaces presenting different radius of
curvature. In particular, the present disclosure relates to the
production of tissues as well as biocompatible and blood-compatible
membranes for making vascular prostheses, concave or convex heart
patches, ellipsoidal cardiac chambers, patches for calcaneal
ulcers, or other components of anatomical parts. The present
disclosure relates also to a method for making such
three-dimensional objects.
BACKGROUND
As well known, many techniques and apparatus exist for making
tissues and biocompatible artificial membranes. In particular, the
main known techniques provide the production of the above described
artificial tissues by extrusion, or by spraying fluid substances.
More in detail, the spraying techniques provide the deposit of a
polymeric solution of synthetic origin by overlapping the polymeric
solution in diluted form and a non-solvent, for example water, to
each other. To this purpose a sprayer is used which sprays both
substances in an alternated way, or, alternatively, two sprayers
are used that deliver the two substances at the same time. The
substances are deposited on a support body which has the same
geometry of the desired tissue products or artificial
membranes.
An example of an apparatus for making such membranes by spraying is
disclosed in WO2004054775. The apparatus uses a plurality of
sprayers, each of which draws from a respective reserve a component
of the biological mixture. A cylindrical support element is then
arranged on which the fluid substances supplied by the sprayers are
deposited, in order to make a coating that forms the desired
membranes. The cylindrical support element can kinematically rotate
about a fixed rotation axis, whereas the sprayers are moved by a
carriage that makes a translational movement along an axis that is
substantially parallel to the rotation axis of the cylindrical
support element. This way, the fluid substances supplied can
deposit on the whole surface of the support element.
However, this solution, as it can be understood, is applicable only
in case the membranes to make have a relatively simple and regular
shape with surfaces presenting a wide radius of curvature and not
too suddenly variable. Such membranes should also have
substantially axisymmetric shape, in order to keep a constant
spraying flow during the rotation of the support element.
A similar apparatus is disclosed in WO2010136983. Even in this
case, the apparatus is used for making a biocompatible structure
that allows regenerating biological tissues with simple shape.
Notwithstanding the above, the apparatus as above described for
making tissues or biocompatible artificial membranes cannot provide
anatomical .prostheses with complex shape, such as concave or
convex heart patches, ellipsoidal cardiac chambers, patches for
calcaneal ulcers, or portions of organs.
U.S. Pat. No. 5,376,117 describes a breast prosthesis for
subcutaneous implants. The prosthesis consists of an outer shell
comprising a non-porous layer of biocompatible polymeric material
and a porous outer layer that coat wraps the non-porous layer. The
outer layer is made by electrostatic deposit of biocompatible
polymeric fibers on the inner layer. Once obtained the
three-dimensional structure, the prosthesis is overturned and
arranged on a spindle that is rotated about its own axis, in order
to make the convex side of the prosthesis.
A breast prosthesis obtained by a process similar to that described
in U.S. Pat. No. 5,376,117 is disclosed also in WO2010/059834.
However, both processes, as described in U.S. Pat. No. 5,376,117
and WO2010/059834, are not suitable for the production of tissues
and biocompatible artificial membranes with complex shape and with
small tolerances, since they cannot ensure an accurate definition
of the modelled forms.
SUMMARY
In general terms, the present disclosure provides an apparatus that
allows the production of a biocompatible three-dimensional object
with complex shape, i.e. not necessarily equipped with significant
symmetries and, in particular with surfaces having different radius
of curvature. The present disclosure may also provide an apparatus
that allows for the production of such three-dimensional object
with high dimensional precision, in order to copy accurately a
pre-designed model.
Further, the present disclosure may provide an apparatus that
allows programming the whole production work so that it can be
carried out in an automatic way.
Briefly, and in general terms, the present disclosure is directed
to an apparatus for making a biocompatible three-dimensional
object. The apparatus includes at least one delivery unit arranged
to deliver at least one biocompatible fluid substance towards a
support body, also called core, that has a matrix surface, to
obtain a coating layer of a predetermined thickness configured for
coating the matrix surface. The biocompatible fluid substance may
include a plurality of particles. The apparatus also includes a
handling unit for determining a relative movement according to at
least 3 degrees of freedom between the support body and the
delivery unit. This is so that the support body may be coated with
the delivered biocompatible fluid substance to obtain a
three-dimensional object having an object surface copying the
matrix surface of the support body. Further, the apparatus includes
a suction and blowing unit is also provided configured to provide a
suction and blowing current arranged to remove from the support
body any surplus particles of the biocompatible fluid substance
supplied by the or each delivery unit. In this example, it is
possible to deposit a uniform predetermined thickness of coating
layer on the matrix surface. The solution provided by the present
disclosure, and in particular the possibility of actuating
relatively the support body and the delivery unit according to at
least 3 degrees of freedom during the coating steps of the matrix
surface, makes it possible to control with high precision the
deposit of the biocompatible fluid substance on the matrix surface.
It is also possible to adjust, in a correspondingly precise way and
as it is needed, the thickness of the layers of deposited fluid
substance. This is possible since the handling unit is capable to
expose the matrix surfaces of the support body to a jet of
biocompatible fluid substance supplied by the delivery unit,
positioning this matrix surface substantially orthogonally to the
jet.
After the deposit of the fluid substances, the coating is removed
from the support body giving rise to the sought three-dimensional
object.
In certain embodiments, the handling unit is arranged to provide a
relative movement according to 4 degrees of freedom,
advantageously, according to 5 degrees of freedom, preferably
according to 6 degrees of freedom. In one embodiment, the handling
unit includes an anthropomorphic robot having a chain of pivot
joints that has an end connected to a fixed base and the other end
connected to a support base to which the support body, and/or the
delivery unit, can be mounted in a removable way. Such chain of
pivot joints is adapted to actuate the support body, and/or the
delivery unit, according to at least 6 degrees of freedom,
supplying higher design precision in generating the sought
three-dimensional object.
Alternatively, the handling unit may include a plurality of
actuators, each of which has one end engaged with a fixed base and
another end engaged with a support base to which the support body,
and/or the delivery unit, can be mounted in a removable way.
In certain embodiments, the actuators may be pneumatic actuators,
hydraulic actuators, electric actuators, or a combination
thereof.
In one embodiment, the suction and blowing unit may replaced with a
suction device, or the suction and blowing unit may include a
suction device and a blowing device. The suction device may be a
fixed suction device. Alternatively, the suction device can be a
movable suction device associated with auxiliary moving means
arranged to move the suction device, in order to follow spatially
the position of the support body during its handling by the
handling unit. This way, any surplus particles of the biocompatible
fluid substance can be removed regardless of the position of the
support body.
In a further exemplary embodiment, the suction device may include a
suction hood integral to the support base and configured to
surround laterally the support body, in order to maximize the
suction of any surplus particles of the biocompatible fluid
substance. A suction tube may also be included which is arranged to
connect pneumatically the suction hood with a suction system. This
way, it is not necessary the implementation of the auxiliary moving
means, since the hood is in an optimal position for suction of any
surplus particles of the biocompatible fluid substance, whichever
is the position of the support body. In one embodiment, the hood
may have a toroidal, cylindrical, or tubular shape.
In one embodiment, the suction device may include a storage
reservoir of any surplus particles or a filter on which such
particles can deposit. Furthermore, the suction or blowing current
from the suction and blowing unit can be generated by a fan or a
compressor located upstream of the suction tube.
In one example, the apparatus may include a first delivery unit
arranged to deliver a first jet of a first biocompatible fluid
substance towards the support body. The first biocompatible fluid
substance being a biomaterial of synthetic origin. The apparatus of
this embodiment also may include a second delivery unit arranged to
deliver a second jet of a second biocompatible fluid substance
towards the support body. The second biocompatible fluid substance
being a non-solvent, for example, water. The second delivery unit
is arranged to direct the second delivery jet towards the support
body, in order to overlap the second delivery jet to the first
delivery jet. This may induce a quick deposit of the synthetic
biomaterial supplied onto the support body by the first delivery
unit, obtaining a filamentous three-dimensional structure.
In yet another embodiment, the apparatus also includes a
counter-mold. The counter-mold may be adapted, once ended the
delivery of the biocompatible fluid substances, to press, in
particular to heat, the coating layer that is deposited on the
support body. This is to obtain a better finishing of the shape of
the three-dimensional object, in addition to improved mechanical
features.
In another embodiment, the apparatus also includes third delivery
unit arranged to deliver a third biocompatible fluid substance, in
particular diluted in solution, both of synthetic and biological
origin. In certain embodiments with two or three delivery units,
with respective delivery of jets of biocompatible fluid substances,
there may be a program means configured for combining the
alternation of such delivery. This way, the step of coating can be
completely automated, and does not require, in normal conditions,
manual monitoring.
Also, in one embodiment, a control means is also provided for
monitoring the thickness of the formed coating layer, in order to
test that the coating layer has thickness corresponding to that of
the designed coating layer. In particular, the designed coating
layer can be provided to apparatus by a control CAD.
The current disclosure is also directed to a method for making a
biocompatible three-dimensional object. The method includes the
step of delivery of at least one biocompatible fluid substance
towards a support body, also called core, which has a matrix
surface. Also, the method includes obtaining a coating layer of
predetermined thickness configured for coating the matrix surface.
The delivery occurring using at least one delivery unit. The method
also includes handling the support body and/or the delivery unit
with a handling unit, in order to provide a relative movement
according to at least 3 degrees of freedom between the support body
and the delivery unit. This is so that the support body is coated
with the delivered biocompatible fluid substance to obtain a
three-dimensional object having an object surface copying the
matrix surface. There may be multiple delivery units and the at
least 3 degrees of freedom may be between the support body and each
of the delivery units. The method also includes removing from the
support body any surplus particles of the or each biocompatible
fluid substance dispensed with a suction and blowing unit. The
removing being carried out through a suction or a blowing step, in
order to make uniform the predetermined thickness of the coating
layer. The suction and blowing unit may be replaced with a suction
device or a blowing device.
In one embodiment, the method includes pressing, in particular hot
pressing, the coating layer that is deposited on the support body.
This step of pressing is carried out at the end of the step of
delivery of the fluid substance.
BRIEF DESCRIPTION OF THE DRAWINGS
The present disclosure will be now shown with the following
description of some exemplary embodiments thereof, exemplifying but
not limitative, with reference to the attached drawings in
which:
FIG. 1 shows an exemplary embodiment of an apparatus including an
anthropomorphic robot arranged to handle the support body;
FIG. 2 shows an exemplary embodiment of an apparatus, which differs
from that of FIG. 1 for the presence of a toroidal hood arranged to
surround the support body;
FIG. 3 shows an exemplary embodiment of the apparatus, which
differs from that of FIG. 2 since the handling unit the support
body does not include an anthropomorphic robot, but a plurality of
linear actuators;
FIG. 4 shows a counter-mold that allows a hot molding of the
coating layer;
FIG. 5 shows a three-dimensional object resulting from the
production process;
FIG. 6A shows a cardiac chamber with a heart patch applied to it;
and
FIG. 6B shows a support from which the heart patch of FIG. 6A is
generated.
DETAILED DESCRIPTION
With reference to FIG. 1, an exemplary embodiment of an apparatus
100 for making a biocompatible three-dimensional object 30 provides
an anthropomorphic robot 132 having a kinematical chain of pivot
joints 133. Such chain of joints 133 is constrained at an end to a
fixed base 134, and at another end to a support base 131 on which
support body 20 engages in a removable way. The chain of pivot
joints 133 of FIG. 1 allows handling the support body according to
six degrees of freedom, allowing an optimum precision when
generating the sought three-dimensional object 30.
In FIG. 1, three delivery units 110,111,112 are shown that are
arranged to deliver three different biocompatible fluid substances.
In particular, first delivery unit 110 is adapted to deliver a jet
of a biomaterial of synthetic origin towards the support body 20.
The second delivery unit 111 is, instead, arranged to deliver a jet
of non-solvent, for example water, overlapping to the jet generated
by first delivery unit 110, in order to induce a quick deposit of
the biopolymeric material supplied onto support body 20 by first
delivery unit 110, allowing to obtain a filamentous
three-dimensional structure. The third delivery unit, finally, is
adapted to deliver a third biocompatible fluid substance diluted in
solution, in particular another biomaterial of synthetic or
biological origin.
Each delivery unit 110,111,112 also has a hydraulic circuit (not
shown in the figure, for example, a cylinder-piston mechanism)
consisting of ducts, with possible valves and pumps, which connect
the or each delivery unit to reservoirs containing the
biocompatible fluid substances.
In this exemplary embodiment, a suction and/or blowing unit 120 is
further provided, adapted to generate a suction and/or blowing
current. This way, the suction and/or blowing unit 120 makes it
possible to level the thickness of the coating layer 35 and to
remove from support body 20 any surplus particles of the
biocompatible fluid substances supplied by the or each delivery
unit 110, 111, 112. The device 120 is also spatially moved by
auxiliary moving means 140, in such a way that this device 120 can
follow spatially the position of support body 20 during its
handling steps by handling unit 130.
In FIG. 2 a second exemplary embodiment is shown, which differs
from an exemplary embodiment of FIG. 1 as from the type of the
device 120. In this exemplary embodiment, device 120 includes a
toroidal suction hood 121, which is integral to support base 131
and is configured to surround laterally support body 20. Toroidal
hood 121 is then joined to a suction tube 122 arranged in turn to
connect pneumatically the suction hood 121 with a suction system
123 that has a compressor to generate a suction flow and with a
storage reservoir containing any surplus particles of the dispensed
fluid substance.
Alternatively, in an exemplary embodiment not shown in the figures,
device 120 is a blowing device including a compressor adapted to
generate a blowing current for removing any surplus particles of
the delivered fluid substance. This way, it is not necessary that
the apparatus includes auxiliary handling unit 140, like the
exemplary embodiment of FIG. 1, since the toroidal hood 121
surrounds laterally the support body 20, whichever is the position
reached by handling unit 130.
In FIG. 3 an exemplary embodiment is shown where handling unit 130,
instead of including the anthropomorphic robot 132 of the previous
figures, includes a plurality of linear actuators 133, each of
which engages, at one end, to fixed base 134, and at another end,
to support base 131. Support body 20 engages in a removable way
with support base 131, like the previous exemplary embodiments. The
handling unit can reach the same degrees of freedom of an
anthropomorphic robot, even if with narrower handling range. The
advantage offered by this solution is shown by a high reduction of
the encumbrance.
In FIG. 4 the step is shown of pressing, in particular to hot
pressing, of the coating layer 35 deposited by the or each delivery
unit 110,111,112, using a counter-mold 150. The coating layer 35 is
then removed from support body 20 and becomes substantially the
final biocompatible three-dimensional object 30, visible in FIG.
5.
Owing to the hot pressing an optimum finishing of the shape of the
three-dimensional object 30 can be achieved, in such a way that
such shape is closest to the designed patch shape, for example
provided by CAD or the like. Such pressing operation also gives to
the three-dimensional object 30 mechanical improved features,
reaching any design standards.
The apparatus 100, as described above, and shown in FIGS. 1 to 5,
provides biocompatible three-dimensional objects 30 of whichever
shape. In particular, biocompatible three-dimensional objects 30
can be manufactured both of simple and regular shape, such as a
tetrahedron or a cone, and of irregular shape and/or with surfaces
which cannot worked out in a simple way, such as a concave or
convex patch or an ellipsoidal patch. Furthermore, biocompatible
three-dimensional objects 30 can be provided having surfaces with
different radius of curvature and/or with different angles.
In FIG. 6A a cardiac chamber of a human heart is shown to which a
biocompatible three-dimensional object 30 is mounted, in particular
a heart patch, consisting of an inner portion 30a and an external
portion 30b.
In FIG. 6B part of the apparatus 100 including the support 20 is
shown, from which the inner portion 30a of the heart patch of FIG.
6A is generated.
The foregoing description of specific exemplary embodiments will so
fully reveal the invention according to the conceptual point of
view, so that others, by applying current knowledge, will be able
to modify and/or adapt in various applications the specific
exemplary embodiments without further research and without parting
from the invention, and, accordingly, it is meant that such
adaptations and modifications will have to be considered as
equivalent to the specific embodiments. The means and the materials
to realize the different functions described herein could have a
different nature without, for this reason, departing from the field
of the invention, it is to be understood that the phraseology or
terminology that is employed herein is for the purpose of
description and not of limitation.
The above described application relates to the MBP project
"Fibrin-based nanostructured materials and platelet factors for
stimulating angiogenesis" ("Materiali nanostrutturati a base di
fibrina e fattori piastrinici in grado di promuovere 1'
angiogenesi") admitted to R.T. financing, R&D Single
Announcement, year 2008, 1.5-1.6 line B-Executive Decree 6744 of
Dec. 31, 2008.
* * * * *